(168 days)
Not Found
No
The summary describes standard ultrasound imaging modes and features, with no mention of AI or ML capabilities. The performance studies focus on safety and wireless functionality, not algorithmic performance.
No
The device is described as a diagnostic ultrasound imaging system, used for "Diagnostic ultrasound imaging or fluid flow analysis," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The "Device Description" also details various imaging modes and measurement capabilities used for diagnostic purposes.
No
The device description explicitly mentions hardware components like scanning modes (B-mode, M-mode, PWD mode, CFM mode, Amplitude Doppler mode), a 3-D module, a Vector Flow Imaging (VFI) module, and an RF wireless function, indicating it is a hardware-based ultrasound system with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that interacts directly with the human body to produce images or analyze physiological processes in vivo.
- Device Description: The description details various ultrasound scanning modes (B-mode, M-mode, PWD, CFM, Amplitude Doppler) and capabilities like measurements, calculations, and needle guidance. These are all functions of an ultrasound system used for imaging and analysis within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. There is no mention of analyzing such specimens in the provided text.
Therefore, the Flex Focus 1202 is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body.
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging. Signal analysis and display.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.
Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.
Product codes
IYO, IYN, ITX
Device Description
Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode.
The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications.
The system can guide biopsy- and puncture needles.
An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.
Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. The patient contact materials are biocompatible.
All transducers used together with Flex Focus 1202 are Track 3 transducers.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Cardiac, Fetal, Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Muskulo-skeletal (conventional and superficial)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device has been evaluated for acoustic output, thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:
- AIUM/NEMA UD-2, Acoustic Output Measurement Standard For Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-3, Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- IEC 60601-1, Medical Electrical Equipment, Part 1: General requirements for safety
- IEC 60601-1-1. General requirements for safety, Part 1:1, Collateral Standard, Safety requirements for medical electrical systems,
- IEC 60601-1-2. General requirements for safety, Collateral Standard, Electromagnetic Compatibility - Requirements and tests
- IEC 60601-2-37, Particular requirements for the safety of ultrasonic diagnostic medical and monitoring equipment
- ISO 14971, Application of Risk Management of Medical Devices
- IEC 62304. Medical Device Software Software lifecycle processes
- IEC 62359, Ultrasonics Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
Additional testing of the RF wireless function was performed at five (5) different sites representing actual user requirements. Several test scenarios was performed and no interference was measured.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
K132335
Page 1 of 4
510(k) Summary:
JAN 10 2014 This summary is provided as part of this Premarket Notification in compliance with 21CRF, Section 807.92.
Submitters name: B-K Medical Address: Mileparken 34, 2730 Herlev, Denmark Phone: +45 44528100 Fax: +45 44528199 Contact person: Randi Hauerberg, Regulatory Affairs Lead Manager Date prepared: July 3, 2013
Trade name: Ultrasound Scanner Flex Focus 1202 Common name: Diagnostic Ultrasound System Classification names: (90 IYO, CFR 892.1560) Ultrasonic Pulsed Echo Imaging System Ultrasonic Pulsed Doppler Imaging System (90 IYN. CFR 892.1560) Diagnostic Ultrasonic Transducer (90 ITX, CFR 892.1570)
Identification of predicate, legally marketed device: B-K Medical Ultrasound Scanner Flex Focus 1202, K081154 B-K Medical Ultrasound Scanner Flex Focus 1202, K123254
Device description:
Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode.
The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications.
The system can guide biopsy- and puncture needles.
An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.
1
Transducers
Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. The patient contact materials are biocompatible.
All transducers used together with Flex Focus 1202 are Track 3 transducers.
Acoustic output
The system controlling the Acoustic Output in the modified Flex Focus 1202 is the same as the system in Flex Focus 1200. The system will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 mW/cm² and M1 ≤ 1.9 (Track 3, non ophthalmic).
The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0
Clinical measurement accuracy
Clinical measurements and calculations are described and accuracies are provided in the User Information.
Thermal, mechanical and electrical safety,
The scanner Flex Focus 1202 has been tested by a recognized Certified Body.
Acoustic Output Reporting
The Acoustic Output Reporting is made according to the standards required by "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH. September 9, 2008"
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.
2
Summary of Technological Characteristics - Predicate Device Compared to Modified Device
| Predicate device | Predicate device | Modified device (this application), | |
|---|---|---|---|
| K081154, | |||
| Ultrasound scanner | |||
| Flex Focus 1202 | K123254, | ||
| Ultrasound scanner | |||
| Flex Focus 2202 | Ultrasound scanner | ||
| Flex Focus 1202 | |||
| Modes of operation | |||
| Ref.: [1] Appendix G | B, M, PWD, CFM 1) | ||
| and combinations | |||
| Tissue harmonic | |||
| imaging. | B, M, PWD, CFM 1)+2) and combinations | ||
| Tissue harmonic | |||
| imaging. | B, M, PWD, CFM 1)+2)+3) and | ||
| combinations | |||
| Tissue harmonic | |||
| imaging. | |||
| Intended Use: | Diagnostic ultrasound | ||
| imaging or fluid flow | |||
| analysis of the human | |||
| body as follows: | Diagnostic ultrasound | ||
| imaging or fluid flow | |||
| analysis of the human | |||
| body as follows: | Diagnostic ultrasound | ||
| imaging or fluid flow | |||
| analysis of the human | |||
| body as follows: | |||
| Indications For Use: | Abdominal | ||
| Cardiac | |||
| Fetal (incl Obstetrics) | |||
| Intraoperative | |||
| Transurethral | |||
| Neurosurgery | |||
| Pediatrics | |||
| Transrectal | |||
| Small Parts (organs) | |||
| Transvaginal | |||
| Peripheral vascular | |||
| Muskulo-skeletal | |||
| (conventional and | |||
| superficial) | Abdominal | ||
| Cardiac | |||
| Fetal (incl Obstetrics) | |||
| Intraoperative | |||
| Transurethral | |||
| Neurosurgery | |||
| Pediatrics | |||
| Transrectal | |||
| Small Parts (organs) | |||
| Transvaginal | |||
| Peripheral vascular | |||
| Muskulo-skeletal | |||
| (conventional and | |||
| superficial) | Abdominal | ||
| Cardiac | |||
| Fetal (incl Obstetrics) | |||
| Intraoperative | |||
| Transurethral | |||
| Neurosurgery | |||
| Pediatrics | |||
| Transrectal | |||
| Small Parts (organs) | |||
| Transvaginal | |||
| Peripheral vascular | |||
| Muskulo-skeletal | |||
| (conventional and | |||
| superficial) | |||
| Features |
-
CFM= Color Flow Mapping=Color Doppler and Amplitude (Power) Doppler.
-
Includes Vector Flow Imaging
-
Includes RF wireless function
A brief discussion of non-clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.
The device has been evaluated for acoustic output, thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:
- AIUM/NEMA UD-2, Acoustic Output Measurement Standard For Diagnostic Ultrasound . . Equipment
- AIUM/NEMA UD-3, Real-time Display of Thermal and Mechanical Acoustic Output . Indices on Diagnostic Ultrasound Equipment
- IEC 60601-1, Medical Electrical Equipment, Part 1: General requirements for safety .
- IEC 60601-1-1. General requirements for safety, Part 1:1, Collateral Standard, Safety . requirements for medical electrical systems,
3
KB32335
Page 4 of 4
- IEC 60601-1-2. General requirements for safety, Collateral Standard, Electromagnetic . Compatibility - Requirements and tests
- IEC 60601-2-37, Particular requirements for the safety of ultrasonic diagnostic medical . and monitoring equipment
- ISO 14971, Application of Risk Management of Medical Devices .
- IEC 62304. Medical Device Software Software lifecycle processes .
- IEC 62359, Ultrasonics Field characterization Test methods for the determination of . thermal and mechanical indices related to medical diagnostic ultrasonic fields
Cleared patient contact materials, electrical and mechanical safety are unchanged.
Additional testing of the RF wireless function was performed at five (5) different sites representing actual user requirements. Several test scenarios was performed and no interference was measured.
Technological characteristics compared to the predicate device
The predicate device has the same major technological characteristics as the subject device described above.
Minor differences consist: Optional RF wireless function.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2014
B-K Medical ApS % Mrs. Randi Hauerberg Regulatory Affairs Lead Manager Mileparken 34 Herlev DK-2730 DENMARK
Re: K132335
Trade/Device Name: Ultrasound Scanner Flex Focus 1202 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: November 29, 2013 Received: December 19, 2013
Dear Mrs. Hauerberg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2-Mrs. Hauerberg
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fdagov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum.
Sincerely yours,
Sm.h.p.)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K132335
Device Name: Ultrasound Scanner Flex Focus 1202
Indications for Use:
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging. Signal analysis and display.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.
Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.
Details on specific Indication for Use forms
AND/OR Over-The-Counter Use _ Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Page 1 of 2
Smh.7)
(Division Sign-Off) Division of Radiological Health/OlR 510(k) _______________________________________________________________________________________________________________________________________________________________________ K132335
7
Diagnostic Ultrasound Indications for Use Form
System: 1202
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | 8 | M | PWD | Tissue | |||||
| amonic | ||||||||||
| imaging | Color | |||||||||
| Doppl | ||||||||||
| er | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify 1) | Other4) | |||||||||
| Ophthalmic | ||||||||||
| Fetal 2) (K081154) | P | P | P | P | P | P | P | |||
| Abdominal {K081154} | P | P | P | P | P | P | P | |||
| Intraoperative | ||||||||||
| (specify) | ||||||||||
| (K081154) | p | P | p | P | P | P | P | |||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| (K081154) | P | P | P | P | P | P | P | |||
| Pediatric (K081154) | P | P | P | P | P | P | P | |||
| Small | ||||||||||
| (specify) | ||||||||||
| Organ | ||||||||||
| (K081154) | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac (K081154) | P | P | p | P | P | P | P | |||
| Transesophageal | ||||||||||
| Transrectal (K081154) | P | P | P | P | p | P | P | |||
| Transvaginal (K081154) | P | P | P | P | P | P | P | |||
| Transurethral (K081154) | p | P | P | P | P | P | p | |||
| Intravascular | ||||||||||
| Peripheral | ||||||||||
| Vascular | ||||||||||
| (K081154), (K123254 ) | ರಿ | P | P | P | p™ | P | P | |||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional (K081154) | P | P | P | P | P | P | P | |||
| Musculo-skeletal Superficial | ||||||||||
| (K081154) | P | p | P | P | P | P | P | |||
| Other (specify) | ||||||||||
| RF Wireless | N" |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:__________________________________________________________________________________________________________________________________________________________
B+M, B+D. B+C, B+D+C. B mode includes Tissue Harmonic Imaging
D is PWD, C is Color Doppler.
Fetal is often called Obstetrics ਨੀ
Vector Flow Imaging 3)
RF wireless function 4)
(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH
Page 2 of 2